Nalgene carboys for bulk storage of drugs and reagents Superior containers to maximize product security All carboys are not created equal

Thermo Scientific™ Nalgene™ containers are made with high-quality resins, and meet the rigorous pharmaceutical high-quality resins that meet pharmaceutical, laboratory, production, laboratory and foodgrade standards. Our and food grade standards. That’s why millions of Nalgene resins are selected to minimize additives and reduce carboys and bottles are at work in bioproduction facilities potential leachables. We do not use plasticizers or fillers, and laboratories around the world. Choose from a and our plastics have low total ash content—a measure wide range of quality carboys and jerricans to fit your of impurities. application requirements—from collecting and mixing reagents, media, and bulk vaccines to storing active Nalgene carboys minimize risk, protecting your pharmaceutical ingredients. valuable products • Leakproof* to help ensure contained materials are not Trust the proven performance of Nalgene containers lost during storage or transport When selecting carboys for critical bioproduction applications, standard laboratory carboys fall far short • Sterile, single-use options to eliminate the need for of what is required for this highly regulated in-house packaging and sterilization industry. We provide the necessary application • Container designs that enable cleaning validations support and documentation, as well as a robust customer notification process. Customization with • Sanitary fitting options for easier cleaning validations fluid transfer options and presterilized carboys and processes are additional benefits you can expect from the • Validation binders and forced extraction studies to Thermo Scientific™ Nalgene™ portfolio. support regulatory compliance Thermo Scientific™ Nalgene™ containers are made with

Shatter-resistant plastic containers are less likely to break than glass. The high-quality materials and construction of Nalgene containers enhance this advantage, assuring protection for your valuable products.

* Our guarantee for a leakproof seal is subject to our standard product warranty, as set forth in the Thermo Fisher Scientific Terms and Conditions of Sale. Our products are leakproof at ambient temperature and pressure when used with their corresponding closures. However, to ensure safe usage, customers are advised to test our containers and closures under conditions of their planned applications. Our leakproof guarantee

We stand behind every Nalgene carboy and Anatomy of a Nalgene carboy jerrican you buy Nalgene carboys and closures are designed, Nalgene carboys and closures are engineered to work manufactured, and supported with the rigorous needs of together with a strong, semi-buttress thread design the pharmaceutical and biologics markets in mind. that prevents stripping. We off er a leakproof guarantee because we manufacture and test both components together as part of our routine quality inspection process (see page 15 for details).

If any Nalgene container doesn’t meet our leakproof standards, simply return it to us and we will replace it—guaranteed.

The seal ring is molded inside the closure. It fi ts tightly against the beveled inner edge (chamfer) of the bottle neck. For dissimilar materials (HDPE carboy with PP closure), no gasket is required. For PP-to-PP sealing, a gasket is added for extra security of the seal.

Threads on bottles and closures have continuous, straight-shouldered semi-buttress threads, not low-quality round threads.

The closure is manufactured and tested to work with the carboy and jerrican threading. The closure and bottle system work together to supply a guaranteed leakproof system.

Nalgene carboys feature a stable base and bottoms with curved inner corners for easy cleaning—no sharp edges or voids that could cause diffi cult cleaning validations or nonhomogeneous stirring

3 Forced extraction study reports

The qualifi cation and validation of production, harvest, Combined with NIST98K, Wiley, and other databases, and containment supplies is an integral part of any these techniques provide the information required to biopharmaceutical application process. Regulatory profi le and identify any signifi cant extractables from each guidelines around the world recommend that the component tested. The evaluation of extractables is based production, storage, and packaging components are on the semi-quantitative estimation of analytes obtained by assessed for extractables or leachables that may interact these techniques. with or impact the product being manufactured. An analysis protocol is available for review upon request To support you, we commissioned studies to identify under a confi dential disclosure agreement (CDA), defi ning compounds that may be extracted from key components the strategy utilized to perform the extraction process. under extreme conditions, and to estimate the quantity of these compounds. These studies are designed to guide you to choose the correct container to show what typical extractable and leachables may be expected when conducting your own studies for submission. 1 2 3 Studies were conducted on two Three extraction solvents were Each extracted solution was diff erent Nalgene carboy systems: used on each unit for the forced subsequently analyzed by: • Nalgene PP carboys and closures extraction process: • Headspace Gas Chromatography/ (TPE gasket and PP white closure) • Water Mass Spectrometry (GC/MS) for volatile and Direct Injection GC/MS • Nalgene sterile HDPE carboys and • Ethanol* for semi-volatile organic compounds closures (PP white closure) • Hexanes* • Liquid Chromatography/Mass • 10% nitric acid** Spectrometry (LC/MS) for non- volatile organic compounds * Direct injection GC/MS and LC/MS analysis. ** ICP/OES analysis only. • Inductively Coupled Plasma (ICP) for metals and elemental extractables using an acid-digested solution

4 In addition to forced extraction studies for the carboy systems, several other studies are available across the Nalgene storage solutions portfolio

Forced extraction studies For specifi c compliance needs, you may fi nd the Description Cat. No. following guides helpful: Nalgene PETG Bottles (System, irradiated at • FDA Guidance for Industry: Container Closure Systems 105-0001 19-28 kGy) for Packaging of Human Drugs and Biologics— Nalgene PETG Bottles (System, irradiated at Chemistry, Manufacturing, and Controls Documentation, 105-0010 20-45 kGy) May, 1999 Nalgene PC Biotainers Bottles (System, US Resin) 105-0002 • EMEA Guideline on Plastic Immediate Packaging Nalgene PP Carboys (System) 105-0003 Materials, CPMP/QWP/4359/03 and EMEA Nalgene PETG Biotainers Bottles (System) 105-0004 CVMP/205/04, European Medicines Agency, May, 2005 Nalgene Sterile HDPE Carboys (System) 105-0007

Understand the diff erence between extraction studies and the leachables studies Extractables These are chemical entities that migrate from any product contact material when exposed to an appropriate solvent under exaggerated conditions of time and temperature. The solvents and conditions are meant to be extremely aggressive and designed to represent “worst-case” results.

Leachables Leachables consist of chemical compounds that are typically a subset of extractables that can migrate from the contact material into stored solutions under normal process conditions and/or accelerated conditions. Leachable studies are designed to produce results representative to actual application and use of the products.

For more information, contact us at rocregsupport@thermofi sher.com

5 High-density polyethylene (HDPE) Ideal for harsh conditions where excellent chemical compatibility is required

• Leakproof PP screw0-top design

• Wide range including heavy-duty for extra-aggressive conditions, amber for light-sensitive products, and wide- mouth design for easy filling and dispensing of liquids

• Round for homogeneous stirring

• Rectangular shape (jerrican) for efficient use of storage space

• Pre-sterilized, single-use options mean no in-house sterilizing or sterilization validation required Recommended applications Media formulation and mixing, aseptic protocols, • Suitable for conditions from –100°C to +120°C aggressive conditions or chemicals, and production where products may adhere to and leach out of containers.

Dimensions Height with Capacity, Closure Length, Width/OD, closure, No. per Description L (gal) size, mm mm (in.) mm (in.) mm (in.) Pk/Cs Cat. No. Single-Use Carboy 20 (5.3) 83B — 284 (11.2) 502 (19.8) 1/6 342289-0050* Single-Use Carboy, Molded-in Handles 33 (8.7) 83B — 381 (15.0) 546 (21.5) 1/1 342289-0075 Amber Carboy 10 (2.6) 83B — 250 (9.8) 383 (15.1) 1/6 2256-7020 Fluorinated Carboy 10 (2.6) 83B — 250 (9.8) 389 (15.3) 1/6 2097-0020 Fluorinated Carboy 20 (5.3) 83B — 282 (11.1) 526 (20.7) 1/4 2097-0050 Rectangular Carboy without Spigot 9 (2.4) 100-415 220 (8.7) 153 (6.0) 360 (14.2) 1/6 2211-0020 Rectangular Carboy without Spigot 20 (5.3) 100-415 320 (12.6) 229 (9.0) 399 (5.71) 1/4 2211-0050 Heavy-Duty Rectangular Carboy 20 (5.3) 70 330 (13.0) 228 (9.0) 406 (16.0) 1/4 2214-0050 Heavy-Duty Wide-Mouth Carboy 20 (5.3) 120 305 (12.0) 203 (8.0) 457 (18.0) 1/4 2241-0050** Jerrican Tethered Angled Closure 6 (1.5) 53B 213 (8.4) 176 (6.9) 335 (13.2) 1/6 2240-0015 Jerrican Tethered Angled Closure 10 (2.6) 53B 246 (9.7) 19 9 ( 7.8) 376 (14.8) 1/6 2240-0025 Jerrican Tethered Angled Closure 20 (5.3) 53B 320 (12.6) 245 (9.6) 4 52 (17.8) 1/4 2240-0050 Jerrican Tethered Top Closure 13 (3.5) 53B 290 (11.4) 18 9 ( 7.4) 378 (14.9) 1/4 2243-0013 Jerrican Tethered Top Closure, 53B, 13 (3.5) 290 (11.4) 18 9 ( 7.4) 378 (14.9) 1/4 2243-9013 38 mm Spigot 38-430 Fluorinated Jerrican 10 (2.6) 53B 246 (9.7) 19 9 ( 7.8) 376 (14.8) 1/6 2242-0025 Fluorinated Jerrican 20 (5.3) 53B 320 (12.6) 245 (9.6) 4 52 (17.8) 1/4 2242-0050 Accessories Handle for 20 L Single-Use Carboy (Stainless Steel) 1/1 2229-0001 53B Replacement Closure and Strap for Jerrican 10/10 712240-1053 38-430 Replacement Closure for Large Nalgene Bottles 12/12 712160-0384 53B Replacement Closure for Large Nalgene Bottles or Carboys 12/12 712160-0530 83B Replacement Closure for Large Nalgene Bottles or Carboys 2/2 712160-0830 * Handle must be purchased separately. ** Designed for powder and solid storage; closure is not leakproof.

6 Polycarbonate (PC) Excellent crystal-clear glass alternative

• Leakproof PP screw-top design

• Autoclavable for in-house sterilization

• Graduations for volume determination at a glance

• Crystal-clear like glass, yet fracture-resistant even at low temperatures

• Smaller validation sizes are available to save on expensive process validations

• Round for homogeneous stirring

• Rectangular shape (jerrican) for efficient use of Recommended applications storage space Where full content visualization is required and for any protocol using glass where a safer alternative is required.

Dimensions Capacity, L Closure size, Length, mm Width/OD, Height with No. per Description (gal) mm (in.) mm (in.) closure, mm (in.) Pk/Cs Cat. No. Round Clearboy 10 (2.6) 83B — 253 (10.0) 394 (15.5) 1/4 2251-0020 Round Clearboy 20 (5.3) 83B — 287 (11.3) 536 (21.1) 1/4 2251-0050 Rectangular Clearboy 9 (2.4) 100-415 220 (8.7) 153 (6.0) 360 (14.2) 1/1 DS2213-0020 Rectangular Clearboy 20 (5.3) 100-415 320 (12.6) 229 (9.0) 399 (15.7) 1/1 DS2213-0050 Validation Bottle 30 mL (1 oz.) 20-415 — 32 (1.3) 75 (3.0) 1/30 DS2127-0030 250 mL Validation Bottle 53B — 74 (2.9) 135 (5.3) 1/6 DS2127-0250 (8.5 oz.) Validation Bottle 2 (0.5) 53B — 123 (4.8) 296 (11.7) 1/12 DS2127-2000 Accessories 53B Replacement Closure for Large Nalgene Bottles or Carboys 12/12 712160-0530 83B Replacement Closure for Large Nalgene Bottles or Carboys 2/2 712160-0830 TPE Gasket for 53B Closure 12/12 712160-0053 TPE Gasket for 83B Closure 5/5 712162-1830

7 Polypropylene (PP) Ideal for in-house cleaning and autoclaving

• Leakproof PP screw-top design with TPE gasket

• Convenient shoulder or attached metal handles for easy carrying and pouring

• Graduations for volume determination at a glance

• Heavy-duty version for vacuum or extreme conditions

• Wide-mouth version for easy cleaning, filling and dispensing

• Version with sanitary dispensing port for use as Recommended applications supply reservoir • Where autoclave-sterilization is required

• Round shape for homogeneity during stirring • Vacuum or extreme use conditions (heavy-duty)

• Rectangular shape (jerrican) for efficient use of • Bulk API or other substances as reservoir for dispensing storage space • Solid or powder material storage (wide-mouth)

Dimensions Width/ Height with No. Capacity, Closure size, Length, OD, mm closure, mm per Description L (gal) mm mm (in.) (in.) (in.) Pk/Cs Cat. No. Rectangular Carboy with SS Handle 9 (2.4) 100-415 220 (8.7) 153 (6.0) 360 (14.2) 1/6 2212-0020 Rectangular Carboy with SS Handle 20 (5.3) 100-415 320 (12.6) 229 (9.0) 399 (15.7) 1/4 2212-0050 Heavy-Duty Carboy with Handles 10 (2.6) 83B — 250 (9.8) 389 (15.3) 1/6 2226-0020 Heavy-Duty Carboy with Handles 20 (5.3) 83B — 282 (11.1) 526 (20.7) 1/4 2226-0050 Wide-Mouth Carboy with Handles 10 (2.6) 100-415 — 250 (9.8) 343 (13.5) 1/6 2235-0020 Wide-Mouth Carboy with Handles 20 (5.3) 100-415 — 282 (11.1) 483 (19.0) 1/4 2235-0050 2250-0020 Carboy with Handles, Autoclavable 10 (2.6) 83B — 250 (9.8) 389 (15.3) 1/6 8250-0020† 2250-0050 Carboy with Handles, Autoclavable 20 (5.3) 83B — 282 (11.1) 526 (20.7) 1/4 8250-0050† 2250-0130 Carboy with Handles, Autoclavable 50 (13.2) 83B — 379 (14.9) 678 (26.7) 1/1 8250-0020† Carboy with Sanitary Flange Bottom, 83B, 1-1/2 in. 10 (2.6) — 250 (9.8) 389 (15.3) 1/1 2640-0020 Autoclavable Tri Clover Carboy with Sanitary Flange Bottom, 83B, 1-1/2 in. 20 (5.3) — 282 (11.1) 526 (20.7) 1/1 2640-0050 Autoclavable Tri Clover Carboy with Sanitary Flange Bottom, 83B, 1-1/2 in. 50 (13.2) — 379 (14.9) 678 (26.7) 1/1 2640-0130 Autoclavable Tri Clover Accessories True Union Clamp for 1-1/2 in. Tri Clover 1/1 2670-0150 Gasket for 1-1/2 in. Tri Clover 6/6 2672-0150 83B Replacement Closure for Large Nalgene Bottles or Carboys 2/2 712160-0830 TPE Gasket for 83B Closure 5/5 712162-1830 † 8250-series products are manufactured in our state-of-the-art facility in Suzhou, China. All other products are manufactured in Rochester, New York. 8 Autoclaving recommendations for Nalgene PC- or PP-based carboys

• The recommended autoclaving cycle is 121°C, 1 bar • Wait until the closure and carboy are completely and/or 250°F, 15 psig for 15–­20 minutes cooled to room temperature before securing closure

• Avoid stacking carboys or using autoclave baskets with • If more than 1 L of liquid is in the carboy, it may take other objects on top several hours or more to reach the target sterilization temperature (typically more practical to autoclave the • Do not secure the openings of the carboy with carboy and sterilize liquid by in-line filtration directly into ™ aluminum foil, blue Steri-Wrap wrap, gauze, cotton, the container) or tape • A disposable carboy vent filter (Cat. No. 223-0030) is • Do not autoclave with the closure—closure must be available featuring a hydrophobic, PTFE membrane, completely removed prior to autoclaving with no which permits sterile venting on slow exhaust/liquid threads engaged autoclave cycles for the Nalgene PP and PC carboys up to 50 L; this vent filter can be used up to 5 times

9 Polypropylene (PP) and polycarbonate (PC) sanitary fitting carboys Perfect for use as supply reservoirs

• Easier to clean than threaded alternatives

• Autoclavable for in-house sterilization

• Round shape for homogeneity during stirring

• Graduations for volume determination at a glance

• PC is crystal-clear like glass

• PP has convenient shoulder handles for easy carrying

Recommended applications • Where cleaning validations are required

• For sterile transfers of product

Dimensions Capacity, Closure Width/OD, Height with No. per Description L (gal) Neck finish size, mm mm (in.) closure, mm (in.) Pk/Cs Cat. No. PC Carboy 20 (5.3) 3 in. Tri Clover — 287 (11.3) 498 (19.6) 1/4 2261-0050 PP Carboy 10 (2.6) 3 in. Tri Clover — 250 (9.8) 353 (13.9) 1/1 2630-0010 PP Carboy 20 (5.3) 3 in. Tri Clover — 282 (11.1) 496 (19.5) 1/1 2630-0020 PP Carboy 50 (13.2) 3 in. Tri Clover — 379 (14.9) 545 (21.5) 1/1 2630-0050 PP Carboy with Sanitary 10 (2.6) — 83B, 1-1/2 in. 250 (9.8) 389 (15.3) 1/1 2640-0020 Bottom Flange Tri Clover PP Carboy with Sanitary 20 (5.3) — 83B, 1-1/2 in. 282 (11.1) 526 (20.7) 1/1 2640-0050 Bottom Flange Tri Clover PP Carboy with Sanitary 50 (13.2) — 83B, 1-1/2 in. 379 (14.9) 678 (26.7) 1/1 2640-0130 Bottom Flange Tri Clover Accessories End Cap PP Loose 3/4 in. 1/1 2665-0075 End Cap PP Loose 3 in. 1/1 2665-0300 True Union Clamp PVDF Loose 3/4 in. Mini 1/1 2670-0075 True Union Clamp PVDF Loose 1 1/2 in. 1/1 2670-0150 True Union Clamp PVDF Loose 3 in. 1/1 2670-0300 Sanitary Gasket Platinum Cured Silicone 3/4 in. Mini 1/6 2672-0075 Sanitary Gasket Platinum Cured Silicone 1 1/2 in. Tri Clover 1/6 2672-0150 Sanitary Gasket Platinum Cured Silicone 3 in. Tri Clover 1/6 2672-0300 Heavy-Duty Clamp Stainless Steel 3 in. 1/1 2685-0300 3 in. Sanitary End Cap PC with two 3/4 in. Sanitary Flanges 3 in. Tri Clover 1/4 2688-2075 3 in. Sanitary End Cap PP with two 3/4 in. Sanitary Flanges 3 in. Tri Clover 1/4 2689-2075

10 Regulatory compliance and customer support

We understand the importance of our customers’ critical applications. That’s why our containers are manufactured in compliance with rigorous quality systems, off ering traceability and controls from raw materials through the fi nished product.

We make it our mission to support our customers’ • Lot-specifi c product certifi cates on demand regulated high-value applications with: • Change control procedures • ISO 13485:2003 and GMP Class I certifi ed • Change notifi cation services and support manufacturing systems • Customer onsite audits by appointment • Resin and product validation data support

Manufacturing certifi cations Certifi cates on demand In 2003, the Thermo Fisher Scientifi c manufacturing Customers can receive a lot-specifi c Nalgene product facilities in Rochester and Fairport, New York achieved certifi cate on demand at any time, day or night, from ISO 13485 compliance. This upgrade superseded the our website. ISO 9001 system that was in place since May 1995. Both sites are also registered as GMP (Good Manufacturing Enter the lot number in the fi eld at the bottom of each Practices) facilities for Class I devices (design exempt) product webpage, and a PDF of the certifi cate is delivered with the US Food and Drug Administration. In addition, instantly for print or download. many of the GMP practices are extended to Nalgene bottle manufacturing, even though the Nalgene bottles Change control procedures themselves are not registered medical devices. In accordance with ISO and GMP requirements, changes to manufacturing procedures, packaging, and product Resin and product validation data specifi cations require methods following specifi c Most of our resins are DMF-registered by the supplier and documented processes for approval and implementation. meet a number of regulatory specifi cations including USP All changes are documented and traceable. Class VI, EP monographs and EU food-contact directives, CONEG, RoHS, CA Prop 65, SARA Title III Sec. 313, and Customer notifi cation services 21 CFR pt 177. Most Nalgene resins are free from ADCs, Customers can receive electronic notifi cation of changes BPA, phthalates, and contact with latex. Compliance to product form, fi t, function, manufacturing location, statements by catalog number are available by contacting tooling, and major process changes by registering in our Regulatory Support. customer change notifi cation database. Register for change notifi cations for a specifi c list of Nalgene items at A validation binder containing compliance data and thermofi sher.com/registercustomernotifi cations product specifi cations is available to customers, provided they have a signed confi dentiality agreement. For additional information, contact our Regulatory Support team at rocregsupport@thermofi sher.com.

11 Low-density polyethylene (LDPE) A high-quality option for everyday use

• Leakproof PP screw-top design

• Convenient shoulder handles for easy carrying and pouring

• Graduations for volume determination at a glance

• Wide-mouth version for easy cleaning, fi lling, and dispensing

• Round for homogeneity during stirring

Recommended applications • Light-duty applications

• Stirring and storage of intermediates

Dimensions Capacity, Closure Height with No. per Description L (gal) Size, mm OD, mm (in.) Closure, mm (in.) Pk/Cs Cat. No. Carboy with Handles 10 (2.6) 83B 250 (9.8) 389 (15.3) 1/6 2210-0020 Carboy with Handles 15 (3.8) 83B 285 (11.2) 429 (16.9) 1/4 2210-0040 Carboy with Handles 20 (5.3) 83B 282 (11.1) 526 (20.7) 1/4 2210-0050 Carboy with Handles 25 (6.5) 83B 287 (11.3) 594 (23.4) 1/4 2210-0065 Carboy with Handles 50 (13.2) 83B 379 (14.9) 668 (26.3) 1/1 2210-0130 Wide-Mouth Carboy with Handles 10 (2.6) 100-415 250 (9.8) 343 (13.5) 1/6 2234-0020 Wide-Mouth Carboy with Handles 15 (3.8) 100-415 286 (11.3) 389 (15.3) 1/6 2234-0030 Wide-Mouth Carboy with Handles 20 (5.3) 100-415 282 (11.1) 483 (19.0) 1/4 2234-0050 Accessories 83B Replacement Closure for Large Nalgene Bottles or Carboys 2/2 712160-0830

12 Quality control, testing, and inspection Nalgene containers are subjected to rigorous scrutiny prior to their release

Resin inspection Our leakproof testing procedures Checks are performed on incoming lots of resin Containers and closures are tested separately with water. material as noted below. All tests are based on Nalgene The term “leakproof” applies to products that meet the container historical data and information supplied by our following criteria: resin manufacturers. 1. Carboy/closure systems with closures smaller than 100 Resin fl ow: Melt fl ow indexes are performed on selected mm are fi lled with water and set on their side, and air lots of incoming resin per ASTM D1238. pressure of 2 psig for 2 minutes is applied. The test is successful when no water escapes. Visuals: A visual comparison of each lot of resin is performed to assure that there is limited lot-to-lot color 2. Carboy/closure systems with closures of 100 mm or variation during manufacturing runs. Granular size and larger are fi lled with water and inverted, and are allowed confi guration of each lot is also checked to ensure that to stand for 15 minutes. The test is successful when no uniform molding will be accomplished. water escapes.

Molding inspection These tests using other liquids may not yield the same Molding inspection is performed in two major steps. results. To ensure safe usage, we recommend testing Step one is the fi rst piece approval stage. Manufacturing with your specifi c combination of container/closure/ must obtain fi rst piece approval from Quality Control before contained material. any parts can be assigned to stock. Warning: Do not use Nalgene carboys or other containers Step two is the critical in-process inspection. Parts are under pressure or vacuum, except those products that continually checked at specifi c intervals during the entire are specifi cally designed, specifi ed, and tested for these production run. We perform a standard Nalgene container conditions. The application of pressure or vacuum to leak test, and parts are inspected for: products not designed for such use may result in failure of the products, damage to property, and/or personal injury. • Physical defects/appearance

• Molding integrity/completeness of threads and sealing ring (closure)

• Dimensions

13 Supporting resin information

Refer to the tables on the following pages for resin properties, torque recommendations for our caps and chemical resistance.

Resin quick reference chart

PP PPCO LDPE HDPE PC PMP PETG FEP PFA ETFE High Temperature 135°C 121°C 80°C 120°C 135°C 145°C 70°C 205°C 260°C 150°C Low Temperature 0°C –40°C –100°C –100°C –135°C 20°C –40°C –270°C –270°C –105°C Autoclavable Y Y N N Y Y N Y Y Y Microwaveable Y Marginal Y N Marginal Y Marginal Marginal Y Y Dry Heat (Oven) N N N N Y Y N Y Y Y Freeze N Y Y Y Y N Y Y Y Y Flexibility Rigid Moderate Excellent Moderate Rigid Rigid Moderate Excellent Excellent Rigid Clarity Translucent Translucent Translucent Translucent Clear Clear Clear Translucent Nearly Clear Translucent Chemical Good Good Good Good Minimal Good Minimal Excellent Excellent Excellent Resistance

Recycling Symbol

Resin Codes • ETFE: ethylene-tetrafluoroethylene • PETG: polyethylene terephthalate glycol • FEP: fluorinated ethylene propylene • PFA: perfluoroalkoxy • FLPE: fluorinated high-density polyethylene • PMP: polymethylpentene (“TPX”) • HDPE: high-density polyethylene • PP: polypropylene • LDPE: low-density polyethylene • PPCO: polypropylene copolymer • PC: polycarbonate • TPE: thermoplastic elastomer

14 Resin properties

Permeability (cc-mil/100 in2- Sterilization5 24 hr.-atm) Max use HDT2 Micro- temp1 temp. Brittleness3 wave- Auto- Dry Disin- Specific Resin (°C) (°C) Temp. (°C) Transparency ability claving Gas heat Radiation fectants gravity Flexibility N O CO LDPE 80 45 –100 Translucent Yes No Yes No Yes Yes 0.92 Excellent 180 500 2,700 HDPE 120 65 –100 Translucent No No Yes No Yes Yes 0.95 Rigid 42 185 580 PP 135 107 0 Translucent Yes Yes Yes No No Yes 0.9 Rigid 48 240 800 PPCO 121 90 –40 Translucent Marginal4 Yes Yes No No Yes 0.9 Moderate 45 200 650 PMP 145 80 20 Clear Yes Yes Yes Yes No Yes 0.83 Rigid 8,000 32,000 115,000 FLPE 120 65 –100 Translucent No No Yes No Yes Yes 0.95 Rigid 42 185 580 ETFE 150 104 -105 Translucent Yes Yes Yes Yes Yes Yes 1.7 Rigid 30 100 250 FEP 205 70 –270 Translucent Marginal4 Yes Yes Yes No Yes 2.15 Excellent 320 750 2,200 PFA 260 166 –270 Translucent Yes Yes Yes Yes No Yes 2.15 Excellent 291 881 2,260 PETG 70 70 –40 Clear Marginal4 No Yes No Yes Some 1.27 Moderate 10 25 125 PC 135 138 –135 Clear Marginal4 Yes 6 Yes No Yes Yes 1.2 Rigid 50 300 1,075 900– TPE 121 <23 <–50 Opaque Yes Yes Yes No Yes Some 0.93 Excellent 31–145 85–646 8,634

Resin properties (continued)

Permeability Water vapor (cc.-mm/m2-24hr.-Bar) transmission Suitable Glass rate (g-mm/m2 Water Non- for food Melting transition 24 hr.-Bar adsorption cyto- and bev. Part 21 Refractive point range temperature Resin N O CO at 38°C, 90% RH) (%) toxic7 use8 CFR index (°C) range (°C) LDPE 69.94 154.28 1,049.09 15.5–23.3 <0.01 Yes Yes 9 177.1520 1.5400 85 to 125 –25 HDPE 16.32 71.88 225.36 4.6–6.2 <0.01 Yes Yes 9 177.1520 1.5100 125 to 138 –25 PP 18.65 93.25 310.84 3.9 <0.02 Yes Yes 177.1520 1.4735 160 to 176 –20 to –5 1.4735– PPCO 17.48 77.71 252.56 4.40 <0.02 Yes Yes 177.1520 150 to 175 –20 1.5100 PMP 3,109.42 12,433.68 44,683.32 775 0.01 Yes No — 1.4630 235 N/A FLPE 16.32 71.88 225.36 4.6 <0.01 Yes Yes 9 177.1615 1.5100 125–138 –125 ETFE 11.66 38.86 97.14 1.65 0.03 Yes Yes 177.1550 1.3580 265 N/A FEP 124.34 291.41 854.82 6.20 <0.01 Yes Yes 177.1550 1.3380 275 N/A PFA 118.07 342.31 878.13 2.00 <0.02 Yes Yes 177.1550 1.3580 302 to 310 N/A PETG 3.89 9.71 48.57 18.13 0.13 Yes Yes10 177.1315 1.57 265 81 PC 19.43 116.57 417.69 115 0.35 Yes Yes 177.158 0 1.5860 N/A 154 0.70– TPE 12.05–56.34 33.03–251 — 0.05 – 5.1 Yes Yes 177.26 0 0 — N/A N/A 3,354.76

1. Ratings based on 5-minute tests using 600 watts of power on exposed, empty labware. CAUTION: Do not 6. Autoclaving reduces mechanical strength. Do not use PC vessels for vacuum applications if they have exceed Max. Use Temp., or expose labware to chemicals where heating causes them to attack the plastic or be been autoclaved. rapidly absorbed. 7. “Yes” indicates the resin has been determined to be non-cytotoxic, based on USP and ASTM biocompatibility 2. Heat deflection temperature is the temperature at which a bar deflects 0.01 in. at 66 psig (ASTM D648). Materials testing standards utilizing an MEM elution technique on a WI38 human diploid lung cell line. may be used above their heat deflection temperatures in non-stress applications; see maximum use temperature. 8. Resins meet requirements of Part 21 CFR section of Food Additives Amendment of the Federal Food and Drug Act. 3. The brittleness temperature is the temperature at which an item made from the resin may break or crack if End users are responsible for validation of compliance for specific containers used in conjunction with their dropped. This is not the lowest use temperature if care is exercised in use and handling. particular packaging applications. 4. Plastic will absorb heat. 9. Acceptable for: • Nonacid, aqueous products; may contain salt, sugar, or both (pH above 5.0) 5. Sterilization: • Dairy products and modifications; oil-in-water emulsions, high or low fat • Autoclaving (121˚C, 15 psig for 20 minutes)—clean and rinse items with distilled water before autoclaving. • Moist bakery products with surface containing no free fat or oil (Always completely disengage thread before autoclaving.) Certain chemicals that have no appreciable effect • Dry solids with the surfaces containing no free fat or oil (no end-test required) and under all conditions as on resins at room temperature may cause deterioration at autoclaving temperatures unless removed with described in Table 2 of FDA Regulation 177.1520 except condition A–high temperature sterilization (e.g. over distilled water beforehand 100°C/212°F) • Gas—Ethylene oxide, formaldehyde, hydrogen peroxide • Dry heat (160˚C, 120 minutes) 10. Acceptable for: • Disinfectants—benzalkonium chloride, formalin/formaldehyde, ethanol, etc. • Alcoholic foods containing not more than 15% (by volume) alcohol; fill and storage temperature not to exceed • Radiation—gamma irradiation at 25 kGy (2.5 MRad) with unstabilized plastic 49°C (120°F) • Non-alcoholic foods of hot fill to not exceed 82°C (180°F) and 49°C (120°F) in storage • Not suitable for carbonated beverages or beer or packaging food requiring thermal processing

15 Chemical resistance classification

Refer to the data below to ensure proper carboy selection for your specific applications.

FEP/ PP/ ETFE FLPE HDPE LDPE PC PETG PFA PMP PPCO TPE* Acids, dilute or weak E E E E E G E E E G Acids, strong and concentrated** E G G G N N E E G F Alcohols, aliphatic E E E E G G E E E E Aldehydes E G G G F G E G G G Bases/alkali E F E E N N E E E F Esters G G G G N F E E G N Hydrocarbons, aliphatic E E G F G G E G G E Hydrocarbons, aromatic G E N N N N E N N N Hydrocarbons, halogenated G G N N N N E N N F Ketones, aromatic G G N N N N E F N N Oxidizing agents, strong E F F F F F E G F N * TPE gaskets. ** Except for oxidizing acids: for oxidizing acids, see “Oxidizing Agents, strong.”

Chemical resistance classification E: 30 days of constant exposure causes no damage. Plastic may even tolerate exposure for years. G: Little or no damage after 30 days of constant exposure to the reagent. F: Some effect after 7 days of constant exposure to the reagent. Depending on the plastic, the effect may be crazing, cracking, loss of strength, or discoloration. Solvents may cause softening, swelling, and permeation losses with LDPE, HDPE, PP, PPCO, and PMP. The solvent effects on these five resins are normally reversible; the part will usually return to its normal condition after evaporation. N: Not recommended for continuous use. Immediate damage may occur. Depending on the plastic, the effect will be a more severe crazing, cracking, loss of strength, discoloration, deformation, dissolution, or permeation loss.

This information is only a summary. Access our chemical resistance database at thermofisher.com/chemicalresistance

16 Torque recommendations

Torque must be properly applied in measured amounts to Because different applications will require different torques Nalgene closures to assure leakproof sealing. To maintain for the same closure/bottle system, it is recommended the closure/carboy seal and minimize back-off during that users determine these values on their own filling shipment, Nalgene closures should be tightly applied using and capping lines. With automatic capping machines, the guidelines provided. application torque must be correlated to removal torque using torque wrenches.* Note: Carboy and closure threads must be dry when torque is applied to the system.

Recommended application torques for Nalgene closures Minimum Torque Maximum Torque** Closure Size, mm in.-lb. 1cm-kg in.-lb. 1cm-kg 11 2 3 3 4 13–415 5 6 7 8 20–415 10 11 14 16 24–415 12 13 17 19 28–415 16 18 22 25 33–415 20 23 28 32 38† 27 31 33 38 38–415 22 25 31 38 38–430 27 31 33 38 43–415 28 32 39 44 48–415 30 34 42 48 48† 30 34 42 48 53–415 33 38 46 52 53B 38 43 53 60 63–415 40 46 56 64 70 44 50 62 71 83B 60 69 84 96

* For details, refer to the Handbook of Package Engineering, Third Edition by Joseph F. Hanlon. ** This number should not be exceeded. It is strongly recommended that users verify these torque numbers, based on their applications. For more information, contact technical support. † Thermo Scientific™ Nalgene™ Biotainer™ container closures

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To meet the increasing demand for biologics worldwide, And while we are fl exible in our approach, we are you need to expect more from suppliers. It isn’t just about uncompromising in our pursuit of performance. Through the products we deliver, but how we do business together. technical engagement, innovative product design, and strategic sourcing programs, we deliver productivity, With a collaborative approach that is grounded in our quality, and assurance of supply so that you can have technical knowledge, we work with you to achieve optimal complete confi dence in the effi ciency and speed of your bioprocessing outcomes. Committed to identifying the biologics development and manufacturing processes. technologies and services that address your needs, from drug development through large-scale commercial That’s our commitment to you, and it’s what we call production, we provide integrated and tailored solutions Bioprocessing by Design. that improve the overall biomanufacturing experience. If a solution doesn’t exist, we’ll build it—together.

Find out more at thermofi sher.com/carboys

For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals. © 2019 Thermo Fisher Scientifi c Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientifi c and its subsidiaries unless otherwise specifi ed. Steri-Wrap is a trademark of Propper Manufacturing Company. COL08939 0319